Study on the Effects of IMU-838 (Vidofludimus Calcium) for Patients with Relapsing-Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called IMU-838 on patients with relapsing-remitting multiple sclerosis (RRMS). Multiple sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. The study aims to assess how well IMU-838 works in reducing disease activity, as observed through magnetic resonance imaging (MRI), and to evaluate its safety and tolerability.

Participants in the study will receive either IMU-838 tablets or a placebo. IMU-838 is available in different doses, including 15 mg, 22.5 mg, and 30 mg tablets, and contains the active substance vidofludimus calcium. The study will compare the effects of these doses to understand their impact on the disease. The trial is designed to be randomized and double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results.

The study will take place over a period of time, with participants undergoing regular MRI scans to monitor changes in their condition. The primary goal is to determine the effectiveness of a 45 mg daily dose of IMU-838 in treating RRMS. Additionally, the study will gather more data on the safety and efficacy of the medication, allowing researchers to model how different doses affect the body. Participants will be closely monitored for any side effects or changes in their health throughout the trial.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of relapsing-remitting multiple sclerosis (RRMS), and disease activity.

Written informed consent is required before any trial-related procedures begin.

2 initial assessment

An initial assessment is conducted, which includes a review of medical history and a physical examination.

Baseline magnetic resonance imaging (MRI) is performed to assess disease activity.

3 treatment allocation

Participants are randomly assigned to receive either IMU-838 or a placebo.

The study is double-blind, meaning neither the participants nor the researchers know who receives the active medication or placebo.

4 medication administration

Participants take IMU-838 tablets orally. The dosage is either 45 mg, 30 mg, or 22.5 mg per day, depending on the group assignment.

The treatment period lasts for 24 weeks, with daily administration of the medication.

5 ongoing assessments

Regular assessments are conducted throughout the trial, including MRI scans to monitor disease activity.

Participants are monitored for any side effects or adverse events.

6 end of main treatment period

At the end of the 24-week main treatment period, a final MRI is performed.

Participants may be eligible for an optional extended treatment period if certain criteria are met.

7 optional extended treatment

Participants who complete the main treatment period and meet specific criteria may continue in an extended treatment phase.

Additional MRI scans are conducted during this period to further assess the treatment’s effects.

8 study completion

Upon completion of the study, participants undergo a final assessment, including a physical examination and review of any side effects experienced.

The study aims to conclude by January 31, 2029.

Who Can Join the Study?

Must be a male or female aged between 18 and 55 years.
Must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS), which is a type of multiple sclerosis where symptoms come and go.
Must have had at least 2 relapses in the last 24 months or at least 1 relapse in the last 12 months, confirmed by a doctor. Also, must have at least 1 Gd+ MS-related brain lesion, which is a specific type of brain change seen on an MRI scan, in the last 6 months.
Must have an Expanded Disability Status Scale (EDSS) score between 0 and 4.0. This is a scale used to measure disability in people with multiple sclerosis.
Female participants must either be unable to have children (due to surgery or menopause) or, if they can have children, must have a negative pregnancy test and agree to use effective birth control methods during the study and for 30 days after.
Male participants must agree not to father a child or donate sperm during the study and for 30 days after. They must use barrier contraception methods if they have a female partner who can have children.
Must be willing and able to follow the study rules and procedures.
Must provide written consent to participate in the study before any study-related activities begin.
For those continuing in the optional extended treatment period, must have completed 24 weeks of the main treatment and have specific MRI scans done.

Who Cannot Join the Study?

Patients who have a different type of multiple sclerosis other than relapsing-remitting multiple sclerosis (RRMS) cannot participate. RRMS is a form of multiple sclerosis where symptoms come and go.
Individuals who are not within the specified age range for the study are excluded. The age range is not specified here, but it is important for eligibility.
Participants who are not able to undergo MRI assessments are excluded. MRI, or magnetic resonance imaging, is a type of scan that helps doctors see inside the body.
Patients who have any medical condition that might interfere with the study or the treatment being tested are not eligible.
Individuals who are pregnant or breastfeeding cannot take part in the study.
Participants who are currently taking certain medications that might interfere with the study drug are excluded.
Patients with a history of drug or alcohol abuse may not be eligible to participate.
Individuals who have participated in another clinical trial recently may be excluded to avoid interference with the study results.
Patients with severe allergies or reactions to medications similar to the study drug are not eligible.
Individuals who have a history of certain serious medical conditions, such as heart disease or liver problems, may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Elias University Emergency Hospital	Bucharest	Romania
MBAL Sveta Marina EAD	Varna	Bulgaria
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Medical Institute Ministry Of Interior	Sofia	Bulgaria
Neuroprotect Sp. z o.o.	Warsaw	Poland
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD	Blagoevgrad	Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD	Sofia	Bulgaria
Diagnostic Consultative Center 14 Sofia EOOD	Sofia	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Neurocentrum Bydgoszcz Sp. z o.o.	Bydgoszcz	Poland
Spitalul Clinic Cai Ferate Constanta	Constanta	Romania
Bnd Cmhapoo Mdpxjyvw	Kajetany	Poland
Mqcouydra Ijlbdeohda Caaxnckl Skyrrulb Sen z ocbv	Warsaw	Poland
Mxktzarc Mvylzyd Afnkwqb	Pleven	Bulgaria
Iuxthltlhugb Pqwoocof Liuphfhl Pxoxu du hbjk no myvt Khnrwt Rrmbye	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	01.02.2019
Germany	Recruiting	01.02.2019
Poland	Recruiting	01.02.2019
Romania	Recruiting	01.02.2019

Trial locations

Investigated drugs:

Vidofludimus Calcium

IMU-838 is a medication being studied for its potential to treat relapsing-remitting multiple sclerosis (RRMS). The trial aims to evaluate how effective IMU-838 is in reducing disease activity, which is measured using MRI scans. The study also looks at the safety and tolerability of the medication in patients with RRMS. IMU-838 is being tested to see if it can help manage the symptoms and progression of this type of multiple sclerosis.

Investigated diseases:

Relapsing-remitting multiple sclerosis

Relapsing-remitting multiple sclerosis – This is a type of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery, or remissions. During a relapse, symptoms can vary widely, including fatigue, numbness, vision problems, and difficulty with coordination and balance. The disease progresses with these relapses and remissions, but the degree of recovery can vary, and some symptoms may persist between relapses. Over time, the disease may lead to a gradual worsening of symptoms, even during remission periods. The exact cause of relapsing-remitting multiple sclerosis is not fully understood, but it involves an immune system attack on the protective covering of nerves. This condition is more common in women than men and typically begins in young adulthood.

Trial ID:

2024-516739-29-00

Protocol code:

P2-IMU-838-MS

NCT ID:

NCT03846219

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of IMU-838 (Vidofludimus Calcium) for Patients with Relapsing-Remitting Multiple Sclerosis

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